Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study
ConditionHER2 + Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorLiu Shu
About this trial
This is a multicenter, open-label, dose-finding trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for paclitaxel oral solution combined with anti-HER2 treatment. Eligible HER2-positive breast cancer patients receive 6 cycles of neoadjuvant THP regimen(paclitaxel oral solution + trastuzumab+pertuzumab) and are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg/m²).
Eligibility criteria
Qualifiers
Female, aged 18 to 70 years.
Histologically confirmed invasive breast cancer by core needle biopsy; clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer staging system (T1cN0M0 excluded).
HER2-positive status defined as IHC 3+ or IHC 2+ with FISH amplification.
Left ventricular ejection fraction (LVEF) ≥ 50%.
Disqualifiers
History of prior invasive breast cancer.
Bilateral breast cancer, or inflammatory breast cancer (e.g., erythema and/or skin involvement and/or pathological evidence of tumor cells in dermal lymphatics).
Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
Prior systemic therapy for breast cancer.
Trial design
Treatments tested in this trial
- Paclitaxel oral solution plus Trastuzumab and Pertuzumab
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Liu Shu
Lead sponsor
The Affiliated Hospital Of Guizhou Medical University
Sponsor institution
Source ClinicalTrials.gov